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Aug 2, 2018

EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect

EMA will shortly publish a high-level outline of the next phase of implementation of its Business Continuity Plan which will come into full effect by 1 October 2018. A press release is currently planned for early next week and a copy will be shared with you under embargo shortly prior to publication.

Read the pdf

FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications

The US Food and Drug Administration (FDA) on Wednesday published a list of surrogate endpoints to help inform drug developer discussions with relevant Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER) review divisions.

The list, which was created thanks to the 21st Century Cures Act, includes surrogate endpoints that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs). It also includes surrogate endpoints that may be appropriate for use as primary efficacy clinical trial endpoints for drug or biologic approvals, although they have not yet been used to support an approved NDA or BLA.

The list, which will be updated every six months, features surrogate endpoints for numerous diseases including acromegaly, different cancers, chronic kidney disease, cystic fibrosis, hepatitis A, B and C, HIV, hypertension and osteoporosis, among others.

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FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics

FDA is announcing two new programs to gather feedback on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. These efforts, the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program, build on stakeholder comments requesting continued dialogue on quality metrics, and provide ways for industry to engage the agency and inform FDA’s use of quality metrics. Feedback from early adopters, manufacturers who implemented quality metrics programs to address significant manufacturing problems, and independent academic research indicates that manufacturers’ overall quality programs benefit from an establishment’s quality metrics program. The new programs provide an opportunity for FDA to continue learning about the advantages and challenges companies have experienced in implementing quality metrics programs.

As part of the Quality Metrics Feedback Program:

  • FDA is encouraging new drug application holders to request Type C Formal Meetings and abbreviated new drug application (ANDA) holders to submit pre-ANDA meeting requests to FDA to initiate discussions on quality metrics for specific products.
  • FDA is also initiating a pilot study to gain feedback from other types of establishments, including active pharmaceutical ingredients (API) establishments, contract manufacturing organizations (CMOs), over-the-counter (OTC) monograph products establishments, or marketed unapproved finished drug products establishments.

The Quality Metrics Site Visit Program:

  • This voluntary site visit program is designed to offer experiential and firsthand learning opportunities to FDA staff involved in development of FDA’s Quality Metrics Program.
  • Staff will gain exposure to robust quality metrics programs through on-site visits, tours of operations, and discussions with establishments to assist staff in further developing FDA’s Quality Metrics Program. FDA staff will also observe how quality metrics data are gathered, collected, and reported to management.

Participation in either of these efforts is voluntary, and the programs are intended to foster the joint efforts of FDA and stakeholders to further understand robust quality metrics programs, which will help FDA, drug manufacturers, and patients. Drug manufacturers will benefit from a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality. Understanding the benefits and challenges of existing quality metrics programs will necessarily inform and improve the development of an FDA program. FDA intends to use quality metrics data to further develop the FDA’s risk-based inspection scheduling (e.g., decreased surveillance inspection frequency for certain establishments), to improve the efficiency and effectiveness of establishment inspections, to improve FDA’s evaluation of drug manufacturing and control operations, and to identify situations in which there may be a risk for drug supply disruption.

FDA Final Guidance for Industry: ANDA Submissions
Amendments to Abbreviated New Drug Applications under GDUFA

On July 3, 2018, the FDA published the final guidance for industry entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.

This final guidance explains how the review goals established as part of the Generic Drug User Fee Amendments (GDUFA II) apply to amendments to Abbreviated New Drug Applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA under section 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 355(j)). It describes amendment classifications and categories and explains how amendment submissions, including updates or changes to a drug master file (DMF) referenced in an ANDA, may affect an application’s review goal dates.

The final guidance also provides additional clarity on the types of facilities related deficiencies that FDA will classify as major, including:

  • Deficiencies that indicate one or more facilities were found inadequate at the time of action
  • Deficiencies that indicate the submission failed to identify facilities required to be listed in the application
  • A new facility that requires comprehensive evaluation

The ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA final guidance finalizes the October 2017 draft version of the guidance. It also supersedes the December 2001 guidance for industry, Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications and the July 2014 draft guidance for industry: ANDA Submissions – Amendments and Easily Correctable Deficiencies under GDUFA, both of which are being withdrawn.

As part of the Commissioner’s Drug Competition Action Plan, the FDA is publishing this guidance to assist in streamlining the ANDA assessment process, provide clarification and assistance to current and potential applicants, and ultimately expand access for patients to lower cost, high quality medicines.

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CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018

The China National Drug Administration released a major draft amendment to the national drug Good Clinical Practice (GCP) guideline, opening a window for public feedback running from July 17 to August 16, 2018.

The proposed amendments follow a previous draft and feedback process that was started in December 2016.

Key changes include clarification on clinical trial applicant’s responsibilities, setting out terms for applicants to establish a quality management system, setting up an independent data monitoring committee, applying risk-based monitoring techniques, while maintaining the primacy of subjects’ rights and safety.

China brings in 60-day CTA window and tacit approvals
Drastically reduced timeline for review and approval for clinical trials in China

The China National Drug Administration (CNDA) has introduced a 60-day window for clinical trial approvals. Mirroring USFDA protocols, if there is no requirement for supplementary information or other amendment to a filing, drug developers can initiate studies once 60 working days have elapsed from the filing’s acceptance by the agency. The rule takes immediate effect.

The notification makes it clear that applicants must apply for a communication meeting with the CDE before filing an Investigational New Drug (IND) dossier as per relevant requirements. The CDE will complete the formal examination within 5 days of filing and issue a formal notice of acceptance unless corrections are required. Then, if no further questions arise from the CDE within 60 days of fee payment, clinical trials can be initiated as per the submitted clinical trial protocol.


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